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| Name | Class |
|---|---|
| NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa | UNKNOWN |
| CINTESIS@RISE, NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa | UNKNOWN |
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The aim of this study is to evaluate the effectiveness of a Weight Loss Maintenance 3 Phases Program (WLM3P) in maintaining long-term weight loss (at least 5% of initial body weight loss at 18 months), compared to a standard low carbohydrate diet (LCD) in adults with obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WLM3P | Experimental | Participants will receive the M3F program. The M3F program is divided into three phases, being the first two of weight loss and the third phase of weight maintenance. |
|
| Low-carb diet | Active Comparator | Participants will receive the low-carb diet program. The low-carb diet program is divided into two phases, being the first of weight loss which follows a low carb diet, and a second phase of weight maintenance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WLM3P | Behavioral | 18 months behavioral weight loss program divided into three phases (first and second phase of weight loss, during 1 month and 5 months, respectively; and a third phase of weight maintenance, during 12 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | Difference between the intervention and control group in the change of weight from baseline to the end of follow-up. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total fat mass | Difference between the intervention and control group in the change of total fat mass, measured by bioimpedance analysis from baseline to the end of follow-up. | 18 months |
| Change in waist circumference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Conceição Calhau, PhD | CINTESIS, NOVA Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NOVA Medical School, NOVA University of Lisbon | Lisbon | 1169-056 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40732984 | Derived | Pereira V, Cuevas-Sierra A, de la O V, Salvado R, Barreiros-Mota I, Castela I, Camelo A, Brandao I, Santo CE, Faria A, Calhau C, Silvestre MP, Moreira-Rosario A. Gut Microbiota Shifts After a Weight Loss Program in Adults with Obesity: The WLM3P Study. Nutrients. 2025 Jul 18;17(14):2360. doi: 10.3390/nu17142360. | |
| 38844671 | Derived |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Low-carb diet | Behavioral | 18 months behavioral weight loss program divided in two phases (first of weight loss during 6 months and a second phase of weight maintenance during 12 months). |
|
Difference between the intervention and control group in the change of waist circumference from baseline to the end of follow-up.
| 18 months |
| Change in body mass index | Change in body mass index (calculated as change in kg/m2, weight in kilograms, height in meters) from baseline to the end of follow-up. | 18 months |
| Change in systolic and diastolic blood pressure | Difference between the intervention and control group in the change in systolic and diastolic blood pressure from baseline to the end of follow-up. | 18 months |
| Change in intestinal microbiota | Difference between the intervention and control group in the change of intestinal microbiota from baseline to the end of follow-up. Bacterial DNA will be extracted from fecal samples. 16SRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage. | 18 months |
| Change in fasting plasma glucose concentrations | Difference between the intervention and control group in the change of serum glucose concentrations from baseline to the end of follow-up. | 18 months |
| Change in fasting plasma insulin concentrations | Difference between the intervention and control group in the change of serum insulin concentrations from baseline to the end of follow-up. | 18 months |
| Change in fasting plasma triglycerides concentrations | Difference between the intervention and control group in the change of serum triglycerides concentrations from baseline to the end of follow-up. | 18 months |
| Change in fasting plasma low density lipoprotein (LDL) concentrations | Difference between the intervention and control group in the change of serum low density lipoprotein (LDL) concentrations from baseline to the end of follow-up. | 18 months |
| Change in fasting plasma high density lipoprotein (HDL) concentrations | Difference between the intervention and control group in the change of serum high density lipoprotein (HDL) concentrations from baseline to the end of follow-up. | 18 months |
| Change in fasting plasma glycated hemoglobin A1c (HbA1c) concentrations | Difference between the intervention and control group in the change of serum glycated hemoglobin A1c (HbA1c) concentrations from baseline to the end of follow-up. | 18 months |
| Change in alanine aminotransferase (ALT) concentrations | Difference between the intervention and control group in the change of alanine aminotransferase (ALT) concentrations from baseline to the end of follow-up. | 18 months |
| Change in aspartate aminotransferase (AST) concentrations | Difference between the intervention and control group in the change of aspartate aminotransferase (AST) concentrations from baseline to the end of follow-up. | 18 months |
| Change in gamma-glutamyl transpeptidase (GGT) concentrations | Difference between the intervention and control group in the change of gamma-glutamyl transpeptidase (GGT) concentrations from baseline to the end of follow-up. | 18 months |
| Change in HOMA-IR | Difference between the intervention and control group in HOMA-IR (homeostasis model assessment of insulin resistance) from baseline to the end of follow-up, calculated using the formula: fasting plasma glucose (mmol/L) x Fasting insulin (mIU/L)/22.5. | 18 months |
| Change in creatinine concentrations | Difference between the intervention and control group in the change of creatinine concentrations from baseline to the end of follow-up. | 18 months |
| Change in vitamin D concentrations | Difference between the intervention and control group in the change of vitamin D concentrations from baseline to the end of follow-up. | 18 months |
| Change in high-sensitivity C-reactive protein (hs-CRP) concentrations | Difference between the intervention and control group in the change of high-sensitivity C-reactive protein (hs-CRP) concentrations from baseline to the end of follow-up. | 18 months |
| Change in sodium concentrations | Difference between the intervention and control group in the change of sodium concentrations from baseline to the end of follow-up. | 18 months |
| Change in potassium concentrations | Difference between the intervention and control group in the change of potassium concentrations from baseline to the end of follow-up. | 18 months |
| Change in magnesium concentrations | Difference between the intervention and control group in the change of magnesium concentrations from baseline to the end of follow-up. | 18 months |
| Pereira V, Barreiros-Mota I, Cortez F, Castela I, Teixeira D, Calhau C, Camila Dias C, Moreira-Rosario A, Silvestre MP. A randomized controlled trial of a weight loss maintenance program in adults with obesity: the WLM3P study. Eur J Clin Nutr. 2024 Aug;78(8):694-702. doi: 10.1038/s41430-024-01454-4. Epub 2024 Jun 6. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |